Comparison of Two Tacrolimus Based Immunosuppressive Regimens in Recipients Receiving Marginal Donor Kidneys (TIGRE)

Astellas

Status and phase: Completed; Phase 3

Conditions: KIDNEY TRANSPLANTATION

Treatments: Drug: mycophenolate mofetil; Drug: steroids; Drug: tacrolimus

Study type: Interventional

Funder types: Industry

Identifiers

NCT00321113

FG-506-02-IT-01

Details and patient eligibility

About

The purpose of this study is to explore the safety and efficacy of two different immunosuppressive regimens (sequential tacrolimus/mycophenolate mofetil [MMF] plus steroids versus tacrolimus plus MMF, following induction with daclizumab) in recipients of marginal donor kidneys.

Full description

An open, multicentre, randomized, parallel group study to compare in marginal old-for-old renal transplant patients the safety and efficacy of two treatments: sequential mycophenolate mofetil/delayed tacrolimus plus steroids vs tacrolimus plus mycophenolate mofetil, in patients requiring induction with anti-IL2 monoclonal antibody.

Elderly (≥50 years) low risk patients (PRA grade ≤50%, in the previous 6 months) receiving an allograft transplantation of marginal kidney(s) from elderly (>65 years) donors (old-for-old allocation) will be randomized to one of the following treatment arms:

Arm1: Sequential mycophenolate mofetil/tacrolimus/steroids

Arm2: Tacrolimus/mycophenolate mofetil/steroid one single dose (perioperatively)

Enrollment: 142 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female patients minimum 60 years of age undergoing a cadaveric kidney transplant
• Patient has end stage kidney disease and is a suitable candidate for primary renal transplantation.
• Donors older than 60 years
• Female patients of child bearing age agree to practice effective birth control during the study.
• Patient has been fully informed and has given written informed consent

Exclusion criteria

• Patient has significant, uncontrolled, concomitant infections and/or severe diarrhoea, vomiting, or active peptic ulcer
• Patient has previously received or is receiving an organ transplant other than kidney or a kidney retransplant
• Any pathology or medical condition that can interfere with this protocol study proposal
• Other exclusion criteria apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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142 participants in 2 patient groups

1

Active Comparator group

Description:

oral

Treatment:

Drug: tacrolimus

Drug: mycophenolate mofetil

2

Experimental group

Description:

oral

Treatment:

Drug: tacrolimus

Drug: steroids

Drug: mycophenolate mofetil